HOME   Cart(1)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 1699-2020 English PDF

US$339.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1699-2020: Tissue engineering medical device products--Chitosan
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1699-2020English339 Add to Cart 4 days [Need to translate] Tissue engineering medical device products--Chitosan Valid YY/T 1699-2020

PDF similar to YY/T 1699-2020


Standard similar to YY/T 1699-2020

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1951   YY/T 1925   

Basic data

Standard ID YY/T 1699-2020 (YY/T1699-2020)
Description (Translated English) Tissue engineering medical device products--Chitosan
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,123
Date of Issue 2020
Date of Implementation 2021-01-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements and test methods for chitosan and its salts used in the preparation of tissue engineering medical device products. This standard applies to the preparation of chitosan and its salts for tissue engineering medical device products.

YY/T 1699-2020: Tissue engineering medical device products--Chitosan

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Tissue engineering medical device products--Chitosan ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0606.7-2008 Tissue engineering medical device product chitosan Released on 2020-02-21 2021-01-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0606.7-2008 "Tissue Engineering Medical Products Part 7. Chitosan", and YY/T 0606.7-2008 In comparison, the main technical changes except for editorial changes are as follows. --- The standard name was changed to "Tissue Engineering Medical Device Product Chitosan"; --- Deleted YY/T 16886 series normative references (only GB/T 16886.1, GB/T 16886.7 and GB/T 16886.12 (Reserved) (see Chapter 2, Chapter 2 of the.2008 edition); --- Added normative reference documents YY/T 0771.1 ~ 0771.3 "Medical Devices of Animal Origin" (see Chapter 2); --- Modified the normative references and the version year number of the "Pharmacopoeia of the People's Republic of China" (see Chapter 2, the.2008 edition of the Chapter 2); --- Modified the classification (see Chapter 4, Chapter 4 of the.2008 edition); --- Modified the requirements for materials of animal origin (see Chapter 5, Chapter 5 of the.2008 edition); --- Modified the requirements for traits (see 6.1, 6.1 in the.2008 edition); --- Added some main characteristic peaks of Fourier transform infrared spectrum (see 6.2, 6.2 in.2008 version); --- Increased content requirements and test methods (see 6.3, 7.3 and Appendix A); --- Modified the test method of the degree of deacetylation (see 7.4, 7.3 of the.2008 edition); --- Modify the requirements and test methods of pH (see 6.5, 7.5, 6.4, 7.4 in.2008 edition); --- Increased the molecular weight and distribution coefficient requirements and test methods (see 6.7, 7.7 and Appendix B); --- Modified the test method of heavy metal content (see 7.8, 7.6 of.2008 edition and appendix A); --- Modified the protein test method (see Appendix C, Appendix B of the.2008 edition); --- Modify the requirements and test methods for the residual amount of ethanol (organic solvent) (see 6.10 and Appendix D, 6.8 and Appendix C of the.2008 edition); --- Removed the ash requirements and test methods (2008 version 6.10, 7.10); --- Increasing the requirements and test methods of ignition residue (see 6.12, 7.12); --- Added requirements and test methods for arsenic salts (see 6.14, 7.14); --- Modified the bacterial endotoxin limit requirements (see 6.15,.2008 version 6.12); --- Modify the sterility test requirements and test methods (see 6.16, 7.16,.2008 version 6.13 and 7.13); --- Added requirements and test methods for microbiological limits (see 6.17, 7.17); --- Deleted the specific requirements and test methods of biological evaluation, and only retained the general rules (see 6.18, 7.18,.2008 version 6.14 and 7.14, 7.15); --- Deleted Chapter 7 inspection rules (see Chapter 8 of the.2008 edition); --- Deleted Appendix D background information (see the.2008 version of Appendix D); --- Added references to "Guidelines for Registration and Application Information of Animal-derived Medical Device Products" and the European Pharmacopoeia (see References); --- Revised the reference number ASTMF2103-01 version number (see References,.2008 version of the reference). Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices. (SAC/TC110/SC3) Centralized. This standard was drafted by. Shanghai Qisheng Biologics Co., Ltd., China National Food and Drug Administration, Qingdao Boyite Biomaterials Co., Ltd. Co., Ltd. The main drafters of this standard. Jiang Lixia, Wei Changzheng, Guo Panpan, Xu Liming, Shao Anliang, Han Baoqin, Song Fulai. Tissue engineering medical device product chitosan

1 Scope

This standard specifies the requirements and test methods of chitosan and its salts used in the preparation of tissue engineering medical device products. This standard applies to the preparation of chitosan and its salts for tissue engineering medical device products.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document. GB/T 191 Graphic mark for packaging, storage and transportation GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management GB/T 16886.7 Biological evaluation of medical devices Part 1. Residue of ethylene oxide sterilization GB/T 16886.12 Biological evaluation of medical devices Part 12. Sample preparation and reference samples GB 18278.1 Damp heat of medical care products sterilization Part 1. Development, validation and routine control of medical device sterilization process Claim GB 18279.1 Sterilization of ethylene oxide for healthcare products Part 1. Development, validation and routine control of medical device sterilization processes System requirements GB 18280.1 Sterilization radiation for health care products Part 1. Development, validation and routine control of medical device sterilization process Claim YY/T 0313 Packaging, marking, transportation and storage of medical polymer products YY/T 0771.1 Medical Devices of Animal Origin Part 1 Risk Management Application YY/T 0771.2 Medical devices of animal origin Part 2. Control of source, collection and disposal YY/T 0771.3 Medical Devices of Animal Origin Part 3. Virus and Transmissible Spongiform Encephalopathy (TSE) Factor Removal and Inactivation confirm Four parts of the "Pharmacopoeia of the People's Republic of China" (2015 edition)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Chitosan chitosan From 2-amino-2-deoxy-D-glucopyranose (GlcN) and 2-acetylamino-2-deoxy-D-glucopyranose (GlcNAc) through β (1 → 4) The resulting linear polysaccharide. Its structural formula is.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1699-2020_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1699-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1699-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1699-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.